Increasing PrEP With Trans Women in the Deep South

NCT ID: NCT05689281

Last Updated: 2023-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2026-07-31

Brief Summary

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The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.

Detailed Description

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The intervention will also assess changes in health care empowerment and support for Social Determinants of Health (SDoH) as mediating the effect of the intervention on PrEP uptake and adherence among trans women.

Conditions

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Hiv

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will be recruited on a rolling basis for a randomized, unblinded, cross-over stepped wedge study design
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PrEP peer navigation

Culturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors

Group Type EXPERIMENTAL

Peer PrEP Navigation

Intervention Type BEHAVIORAL

Ecological momentary assessments to identify and address stressors related to social determinants of health (e.g., housing, substance use, mental health), and motivational interviewing to support participants' health care empowerment and progression along the PrEP continuum.

Interventions

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Peer PrEP Navigation

Ecological momentary assessments to identify and address stressors related to social determinants of health (e.g., housing, substance use, mental health), and motivational interviewing to support participants' health care empowerment and progression along the PrEP continuum.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated informed consent form
* Declaration of willingness to comply with all study procedures and availability during the study
* Age 18 years old or older
* Male sex designated at birth
* Identify as trans woman, woman or another gender identity not associated with being a man
* Desire to use or re-start PrEP
* HIV uninfected
* Speaks English or Spanish
* Live in the New Orleans metropolitan statistical area (which includes 8 parishes)

Exclusion Criteria

* Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)
* Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity
* Concurrent or planned enrollment in a research study that provides PrEP
* Unwilling to attend quarterly follow-up visits, which will include survey participation
* Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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CrescentCare

OTHER

Sponsor Role lead

Responsible Party

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Narquis Barak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NO/AIDS Task Force d.b.a. CrescentCare

New Orleans, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Narquis Barak, MS

Role: CONTACT

504.821.2601 ext. 1058

Erin Meek, DrPH

Role: CONTACT

628-217-6113

Facility Contacts

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Narquis Barak, MA

Role: primary

504-821-2601

Other Identifiers

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10275

Identifier Type: -

Identifier Source: org_study_id

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